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| Name | Class |
|---|---|
| Air Liquide SA | INDUSTRY |
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This is a prospective interventional study to determine whether the profile of volatile organic compounds (VOCs) present in exhaled air (VOLATOLOM) is reproducible in stable severe COPD (Chronic Obstructive Pulmonary Disease) patients.
After being informed about the study, all patients giving written informed consent and meeting the eligibility criteria will undergo 4 visits spaced 4 to 6 weeks apart.
The first visit V1 will be about 45 minutes duration. The others ones (V2 to V4) will be about 30 minutes duration.
All sessions will be carried out in the Pneumology Department of the Foch Hospital, volatolomics platform (Exhalomics®).
Exhalation collection will be performed at each visit in order to perform the volatolom analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VOC analysis | Other | VOC analysis in exhaled air in patients hospitalised for stable severe COPD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VOC analysis | Device | VOC analysis in exhaled air with e-noses and mass spectrometry. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Volatolom measurements by mass spectrometry | Analysis of the volatolom by mass spectrometry for stable severe COPD patients during four successive visits, 4 to 6 weeks apart. | 4 months |
| Volatolom measurements by electronic-noses | Analysis of the volatolom by electronic noses for stable severe COPD patients during four successive visits, 4 to 6 weeks apart. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in the profiles of VOCs in the exhaled air according to the smoking habits | Analyze the differences in the exhaled VOCs prints generated by the eNoses and mass spectrometry data processed with the ptairMS R package (https://github.com/camilleroquencourt/ptairMS) according to smoking habits (ex-smokers versus active smokers), | 4 months |
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Inclusion Criteria:
Severe COPD (FEV ≤ 50% of theoretical values)
History of at least one severe COPD exacerbation (treated with antibiotics and / or oral corticosteroid therapy) in the two years preceding the study;
Ex-smokers (at least 6 months of withdrawal) or active daily smokers of more than 10 pack-years
Severe dyspnea at baseline (mMRC stage ≥ 2)
Aged 40-85 years inclusive
Fluency in French
A signed and dated written informed consent is obtained prior to participation
Affiliated to a health insurance plan
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philippe Devillier, MD PhD | Contact | 0146252791 | +33 | p.devillier@hopital-foch.com |
| : Elisabeth Hulier-Ammar, PhD | Contact | drci-promotion@hopital-foch.com |
| Name | Affiliation | Role |
|---|---|---|
| Philippe Devillier, MD PhD | Hopital Foch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foch hospital | Recruiting | Suresnes | 92151 | France |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Differences in the profiles of VOCs in the exhaled air according to the background therapy | Analyze the differences in the exhaled VOCs prints generated by the eNoses and mass spectrometry data processed with the ptairMS R package (https://github.com/camilleroquencourt/ptairMS) according to the backgrounf therapy (with or without antibiotic/ oral corticosteroid therapy...) | 4 months |
| Compare VOCs profiles in the exhaled air to those of patients with exhacerbated COPD (VOC-BPCO-Exa study sponsored by Hopital Foch) | Comparison of the exhaled VOCs prints generated by the eNoses and mass spectrometry data processed with the ptairMS R package (https://github.com/camilleroquencourt/ptairMS) determined from severe COPD patients at stable state included in the study versus VOCs profiles of patients with exhacerbated COPD (VOC-BPCO-Exa study sponsored by Hopital Foch) | 4 months |
| Compare VOCs profiles in the exhaled air to those of healthy subjects smokers or non-smokers (VOLATOPNEE study sponsored by Hopital Foch) | Comparison of the exhaled VOCs prints generated by the eNoses and mass spectrometry data processed with the ptairMS R package (https://github.com/camilleroquencourt/ptairMS) determined from severe COPD patients at stable state included in the study versus VOCs profiles of healthy subjects smokers or non-smokers (VOLATOPNEE study sponsored by Hopital Foch) | 4 months |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |